Iowa Admin. Code r. 657-20.23

Current through Register Vol. 47, No. 11, December 11, 2024

Rule 657-20.23 - Records

(1)Retention. All records required by this chapter shall be retained as original records of the pharmacy or outsourcing facility and shall be readily available for inspection and photocopying by agents of the board or other authorized authorities for at least two years following the date of the record.

(2)Required elements. Records shall allow for the identification of the following:

a. All ingredients used in compounding, including manufacturer or National Drug Code (NDC), lot number, and expiration date.

b. The compounding steps involved in the preparation.

c. All personnel involved in compounding.

d. All personnel involved in reviewing compounded preparations.

(3)Batch disbursements. The pharmacy or outsourcing facility shall maintain records documenting the disbursements from each batch of a compounded preparation.

Iowa Admin. Code r. 657-20.23

Adopted by IAB October 14, 2015/Volume XXXVIII, Number 08, effective 11/18/2015

Amended by IAB September 21, 2022/Volume XLV, Number 6, effective 10/26/2022